NDA

NDA. Means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act (21 U. S. C. §352(d)), or Biologics License Application submitted to the Food and Drug Administration, or any successor application or procedure required for Approval to commence sale of a Licensed Product in the United States.

NDA. Means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign application, registration or certification.

NDA. Shall mean a New Drug Application or an Abbreviated New Drug Application as defined in 21 U.S.C. § 355.

NDA. Shall mean a New Drug Application for a Product in accordance with the requirements of the FDA. 1.36.

NDA. Cephalon's NDA No. 20-717 filed with the FDA, and all supplements and amendments filed thereto.

NDA. Shall mean a New Drug Application in the U.S. as defined in Title 21 of the U.S. Code of Federal Regulations, Section 314.50, et. seq.

NDA. Collectively means all individual confidentiality agreements dated prior to the date hereof, between the Parties, as amended to date and as such may be amended from time to time after the date hereof.

NDA. Means a New Drug Application filed with the FDA in accordance with applicable regulations and requirements of the FDA.

NDA. Means the nondisclosure agreement between the Parties dated February 25, 2011.

NDA. Shall mean the Non-Disclosure Agreement between the Parties, dated August 4, 2009. 2 ***Confidential Treatment Requested